The CDC's Advisory Committee on Immunization Practices (ACIP) voted 8–3 on December 5, 2025 to end the recommendation that every U.S. newborn receive a hepatitis B shot within 24 hours of birth. The committee had been recently overhauled under HHS Secretary Robert F. Kennedy Jr.; acting CDC Director Jim O'Neill ratified the change on December 16, 2025.
For babies whose mothers test negative for hepatitis B, the panel now advises individualized decision-making with parents and suggests delaying the first dose until at least two months of age. The birth dose stays for infants whose mothers are infected or whose status is unknown.
The change reverses a core element of a 1991 strategy credited with driving a ~98–99% decline in hepatitis B infections among U.S. children. Major medical societies, vaccine makers, state health officials, and former ACIP members warn it could increase perinatal and early-childhood hepatitis B cases, particularly where maternal screening fails. Insurers like Cigna have confirmed continued coverage, but critics see it as a test case for broader rollbacks of the childhood immunization schedule under President Trump.
ACIP vote to end universal birth‑dose recommendation
The reconstituted ACIP voted 8 in favor and 3 against shifting from universal hepatitis B vaccination at birth to individualized decision-making for infants of hepatitis B–negative mothers.
≈98–99%
Decline in pediatric hepatitis B infections since 1991
Universal infant hepatitis B vaccination, including the birth dose, is credited with eliminating the vast majority of hepatitis B infections in U.S. children and young adults since the early 1990s.
0.5%
Pregnancies to hepatitis B–positive women in the U.S.
An analysis presented to ACIP estimated that about 0.5% of U.S. pregnancies are in women who test positive for hepatitis B surface antigen, with most in women born in high-endemicity countries—making maternal screening and birth-dose policies critical for prevention.
≤16%
Share of pregnant women not screened 2015–2019
Up to 16% of U.S. pregnant women were not screened annually for hepatitis B between 2015 and 2019, leaving hundreds of thousands of newborns each year potentially dependent on the universal birth-dose “safety net” rather than documented maternal status.
≈1,400 / year (modeled)
Potential additional infections under new policy
Modeling cited by critics suggests the ACIP change could result in up to ~1,400 extra hepatitis B infections and hundreds of additional deaths per year in future birth cohorts, depending on implementation and coverage.
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16 events
Latest: January 8th, 2026 · 5 months ago
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January 2026
ASGE notes CDC adoption of ACIP hepatitis B recommendations
LatestPolicy Implementation
The American Society for Gastrointestinal Endoscopy reports CDC has replaced universal birth-dose recommendation with delay to two months for infants of hepatitis B-negative mothers, while maintaining coverage consistency across payment programs; ASGE had previously opposed the change.
December 2025
ACIP votes 8–3 to end universal hepatitis B birth-dose recommendation
Policy Decision
After contentious debate, ACIP votes 8–3 to replace the universal newborn hepatitis B birth-dose recommendation for infants of hepatitis B–negative mothers with "individual-based decision-making" and suggests delaying the first dose until at least two months of age. Birth-dose recommendations for infants of infected or unknown-status mothers remain unchanged.
Backlash from medical groups, states, and vaccine makers
Reaction
The American Academy of Pediatrics, American Medical Association, liver and infectious-disease societies, and state health departments in Colorado and Oregon publicly oppose the ACIP decision and urge maintaining universal newborn vaccination. Merck and GSK, makers of hepatitis B vaccines, warn that the change threatens decades of progress and could lead to more infections and deaths.
Sen. Bill Cassidy urges CDC to reject ACIP change
Political Response
Senator and hepatologist Bill Cassidy, chair of the Senate HELP Committee, calls ACIP’s move a mistake and urges acting CDC Director Jim O’Neill not to sign the new recommendation, warning it will result in more hepatitis B infections and liver disease.
Trump orders review of U.S. childhood vaccine schedule
Executive Action
Following the ACIP vote, President Trump orders a federal review of the U.S. childhood vaccine schedule, asserting that the United States is an "outlier" in the number of vaccines administered and signaling potential further rollbacks beyond hepatitis B.
ACIP delays initial vote amid confusion over hepatitis B language
Meeting
During an ACIP session in Atlanta, members express frustration that last-minute changes have left them unclear on what exactly they are voting on regarding the hepatitis B birth dose. The panel votes 7–3 to delay the decision until the next day.
Liver and infectious-disease societies warn against abandoning birth dose
Professional Response
AASLD and five partner societies issue a joint statement calling ACIP’s planned move to scrap universal hepatitis B birth-dose recommendations alarming and urging that the birth dose be maintained to prevent thousands of infections and tens of thousands of deaths.
September 2025
ACIP backs universal hepatitis B testing in pregnancy, delays birth-dose vote
Policy
ACIP votes to recommend that all pregnant women be tested for hepatitis B, a step that will be covered by federal insurance programs, but amid confusion over draft language, the committee tables a vote on whether to change the universal newborn birth-dose recommendation.
June 2025
Reconstituted ACIP targets childhood schedule for review
Meeting
At its first meeting under new leadership, ACIP chair Martin Kulldorff announces that workgroups will re-examine the U.S. childhood immunization schedule and long-approved vaccines, explicitly questioning whether it is "wise" to give every newborn a hepatitis B shot before discharge.
New ACIP members named, including vaccine skeptics
Governance
HHS unveils eight new ACIP advisers, including Martin Kulldorff, Joseph Hibbeln, Robert Malone, and Cody Meissner. Critics warn the panel could now undermine long-established vaccine recommendations, including for hepatitis B.
HHS reconstitutes ACIP, firing all 17 members
Governance
Kennedy announces that all 17 ACIP members have been "retired" and that the committee will be fully reconstituted, arguing that a clean sweep is needed to restore public trust and eliminate conflicts of interest.
March 2025
Reports emerge that RFK Jr. plans ACIP shake-up
Governance
Bloomberg Law reports that HHS Secretary Robert F. Kennedy Jr. is moving to remove the sitting members of ACIP as part of a broader effort to revamp vaccine approvals and oversight.
August 2017
AAP policy calls for hepatitis B birth dose within 24 hours
Clinical Guidance
The American Academy of Pediatrics issues a policy statement endorsing ACIP’s recommendation that all infants ≥2,000 g receive the first hepatitis B dose within 24 hours of birth, describing it as a critical safety net against perinatal transmission and maternal testing failures.
December 2005
ACIP tightens guidance: birth dose before hospital discharge
Policy
ACIP revises recommendations to specify that all medically stable newborns weighing at least 2,000 g receive a hepatitis B vaccine dose before hospital discharge, further institutionalizing the birth dose as a universal practice.
July 1999
Temporary delay of hepatitis B birth dose over thimerosal concerns
Policy
The American Academy of Pediatrics and the U.S. Public Health Service recommend postponing the first hepatitis B dose until age 2–6 months for infants of hepatitis B–negative mothers to reduce exposure to thimerosal, a mercury-containing preservative, while maintaining a birth dose for infants of infected or unknown-status mothers. By September 1999, thimerosal-free vaccine becomes available and CDC urges resumption of routine newborn vaccination, but coverage remains depressed for months and confusion persists.
November 1991
ACIP endorses universal infant hepatitis B vaccination
Policy
ACIP issues a comprehensive strategy to eliminate hepatitis B virus transmission in the United States, recommending hepatitis B vaccination for all infants, with the first dose administered during the newborn period, preferably before hospital discharge but no later than two months of age.
Historical Context
3 moments from history that rhyme with this story — and how they unfolded.
1 of 3
July 1999 – mid-2000
1999 U.S. Suspension of the Hepatitis B Birth Dose Over Thimerosal
In July 1999, amid theoretical concerns about mercury exposure from thimerosal-containing vaccines, the American Academy of Pediatrics and the U.S. Public Health Service recommended postponing the first hepatitis B dose until 2–6 months of age for infants whose mothers tested negative for hepatitis B, while maintaining birth dosing for infants of infected or unknown-status mothers. Within months, thimerosal-free hepatitis B vaccines became available, and CDC urged hospitals to resume routine birth dosing. Nevertheless, studies found that birth-dose coverage and completion of the three-dose series fell substantially for infants born during and shortly after the suspension, reflecting confusion created by rapidly changing guidance.
Then
Birth-dose coverage dropped sharply and remained depressed for months after the recommendation was rescinded; hundreds of thousands fewer newborns received timely hepatitis B vaccination, and more children were under-vaccinated by 19 months of age.
Now
Over the following years, universal birth-dose recommendations were reaffirmed, thimerosal was largely removed from pediatric vaccines, and coverage gradually recovered. The episode is now cited as a cautionary tale about the lasting impact of abrupt, poorly communicated vaccine-policy changes.
Why this matters now
The 1999 suspension shows how even temporary, narrowly targeted changes to hepatitis B birth-dose guidance can reduce coverage and sow long-lasting confusion. The 2025 ACIP decision goes further—abandoning universal birth-dose recommendations for a large segment of infants—raising concerns that the coverage and trust losses could be deeper and more sustained.
2 of 3
2013 – 2021 (with continuing effects)
Japan’s Suspension of Proactive HPV Vaccine Recommendations
In June 2013, Japan’s Ministry of Health, Labour and Welfare suspended its proactive recommendation for the HPV vaccine following media reports of alleged adverse events, even though subsequent reviews found no causal link. Routine vaccination technically remained available, but uptake among adolescent girls plummeted from more than 70% to below 1% within months, creating a so-called "lost generation" of unvaccinated young women. Modeling studies project that the prolonged suspension will result in more than 20,000 excess cases of cervical cancer and over 5,000 additional deaths.
Then
Coverage collapsed and stayed extremely low for years despite scientific evidence supporting vaccine safety, as official ambivalence reinforced public fear and undermined trust.
Now
Japan resumed proactive HPV vaccine recommendations in 2021, and catch-up campaigns are under way, but the country faces a long-term burden of preventable cervical cancer in cohorts who missed vaccination.
Why this matters now
Japan’s experience illustrates how retreating from strong, proactive vaccine recommendations—without clear scientific justification—can drive dramatic, long-lived declines in uptake and substantial future disease burden, even if vaccines remain available on paper. Critics of the 2025 ACIP decision fear a similar dynamic for hepatitis B birth dosing in the U.S.: a shift from universal recommendation to "it’s your choice" that, in practice, means many at-risk children go unprotected.
3 of 3
Late 1990s – mid-2000s
The UK MMR Vaccine Scare and Measles Resurgence
After the publication of Andrew Wakefield’s discredited 1998 paper claiming a link between the MMR vaccine and autism, MMR vaccination coverage in the United Kingdom fell from about 92% in 1996 to 84% in 2002, and in some London boroughs as low as 61% by 2003. In the years that followed, measles cases surged: confirmed cases rose from 56 in 1998 to hundreds per year, including the first measles death in the UK since 1992.
Then
Falling vaccine coverage led directly to measles outbreaks and severe illness in unvaccinated children, forcing public health campaigns and emergency responses.
Now
Although coverage later improved after intense public-health efforts and the retraction of Wakefield’s paper, the episode left persistent vaccine hesitancy and highlighted how quickly hard-won herd immunity can be lost.
Why this matters now
The MMR saga underscores how politicized or poorly evidenced challenges to long-standing vaccine recommendations can erode uptake and trigger the return of controlled diseases. The 2025 hepatitis B decision similarly pits an expert consensus on safety and benefit against a reconfigured advisory body influenced by vaccine-skeptical narratives, raising fears of a slow-burning resurgence in a disease many clinicians now rarely see in children.
